Content and quality of 2000 controlled trials in schizophrenia over 50 years
Content and quality of 2000 controlled trials in schizophrenia over 50 years
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DOI：
10.1136/bmj.317.7167.1181
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发表时间：
1998-10-31
影响因子：
--
通讯作者：
Adams, C
中科院分区：
文献类型：
--
作者：
Thornley, B;Adams, C
目的对精神分裂症治疗相关干预研究的内容和质量进行全面调查。设计数据来自科克伦精神分裂症组登记的2000项试验。主要结局指标包括出版类型和日期、来源国、语言、研究规模、治疗环境、参与者群体、干预措施、结局、结果在美国进行的以医院为基础的药物试验在样本中占主导地位（54%）。一般来说，研究时间短（54% < 6周），规模小（平均患者人数65），报告不佳（64%的质量评分小于或等于2（最高评分5））。超过600种不同的干预措施进行了研究，在这些试验中，和640种不同的评级量表被用来衡量outcome.Conclusions半个世纪的研究有限的质量，持续时间和临床效用留下了很大的范围，以及计划，进行和报告的试验。药品监管部门应规定，在给予化合物日常使用许可之前，必须有解释性和实用性试验的结果。
Objective To provide a comprehensive survey of the content and quality of intervention studies relevant to the treatment of schizophrenia.Design Data were extracted from 2000 trials on the Cochrane Schizophrenia Group's register.Main outcome measures Type and date of publication, country of origin, language, size of study, treatment setting, participant group, interventions, outcomes, and quality of study.Results Hospital based drug trials undertaken in the United States were dominant in the sample (54%). Generally, studies were short (54% < 6 weeks), small (mean number of patients 65), and poorly reported (64% had a quality score of less than or equal to 2 (maximum score 5)). Over 600 different interventions were studied in these trials, and 640 different rating scales were used to measure outcome.Conclusions Half a century of studies of limited quality, duration, and clinical utility leave much scope for well planned, conducted, and reported trials. The drug regulatory authorities should stipulate that the results of both explanatory and pragmatic trials are necessary before a compound is given a licence for everyday use.